2025 ASH | 强生公布 CD19/CD20 双靶点 CAR-T 1b 期最新临床进展与生物标志物分析！

医麦客2025-12-24

2025 年 12 月 24 日医麦客新闻 eMedClub News本月 9 日，强生在第 65 届美国血液学会（ASH）年会上以口头报告形式，更新了其双靶点 CAR-T 疗法 Prizlo-cel（JNJ-90014496）的 1b 期临床试验数据及生物标志物关联分析。这一管线源自强生与西比曼 2023 年达成的全球合作，而强生官网更将其纳入“年销售峰值超 50 亿美元”的重磅管线矩阵。6 ...

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CAR-T，该结构能有效防止抗原逃逸并且减少脱靶效应。目前也仅有约 40% 的患者通过现有的单抗原靶向 CD19 CAR-T 细胞疗法获得长期缓解。从临床数据上看，51 名 R/R LBCL 患者在无预防性治疗情况下接受给药，3 级 ICANS 和 CRS 发生率分别仅为 8% 和 4%。ORR 达 91%，CR 率 75% 该数据显著优于传统 CD19 CAR-T 历史数据。观察 ICANS 分级与 CAR-T 细胞水平可以发现，三组血药浓度的中位数水平都非常接近。Grade 3 中位数略高，但 Grade 1 和 Grade 2 中同样有高峰值浓度样本，并未显示 ICANS 严重程度与 CAR-T 细胞扩增有显著关联。另外从 CRS 与 CAR-T 细胞水平上可以看出：轻中度 CRS 与更高的 CAR-T 扩增相关（Grade 1-2 组血药浓度更高），但重度 CRS 与 CAR-T 扩增的关系不明显。综上我们可以看出 Prizlo-cel 在安全性和有效性上的平衡。除了在疗效、安全性上的数据，强生在口头报告中也展现了多项生物标志物与临床结果的关系比如不同 CD20 和 CD19 抗原表达水平下，CAR-T 细胞扩增及高完全缓解率。不同测试剂量下 CAR-T 细胞扩增与持久性比对，B 细胞耗竭程度等。总的来看，强生（Johnson & Johnson）与西比曼生物科技（AbelZeta）联合开发的这一款新型 CD20/CD19 双靶点 CAR-T 细胞疗法通过创新设计克服传统单靶点 CAR-T 的抗原逃逸和肿瘤异质性局限。其全球 1b 期临床试验数据显示，该疗法在安全性、有效性及生物标志物关联分析中均表现出显著优势，为 R/R LBCL 患者提供了更深层的疾病缓解并有望延长其无进展生存期。后续 2 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